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Is CSA Really a Game Changer for the Life Science Industry?

By Brian Stephens, June 11, 2020

Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA?

Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto life science companies for the past two decades, with less-than-desired results. The FDA's upcoming CSA guidance promises to be a useful tool to help the industry finally achieve this elusive goal.

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Data Centers are Constantly Evolving

By Jennifer Lauria Clark, February 7, 2018

Growing up, we did not have a home computer in my family until I was 11 years old. We were fortunate enough that my momma brought home an Apple desktop over the summer; my sister and I dedicated all of our computer time to Oregon Train and Number Munchers. (“Like” this post if you remember those games on 3.5 x 5 floppy disks!)

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The Data Life Cycle

By John Hannon, October 10, 2017

The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of:  Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction

A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify, assess, mitigate, and communicate potential data integrity issues. Systems supporting the data integrity should be validated for their intended use, and boundaries for the data should be identified. Throughout the data process, data must be secured from modification or deletion by unauthorized personnel, and changes to the data must be captured in audit trails or through appropriate procedures.

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How to Understand ASTM E2500